MedicalResearch.com Interview with:
Paul Burton MD, PhD, FACC
Vice President, Medical Affairs
Janssen Scientific Affairs, LLC.
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Treatment of venous thromboembolism (VTE) is complicated among morbidly obese patients. Current guidelines do not recommend use of Factor Xa inhibitors in these patients due to limited clinical data available. That’s why Janssen undertook this study to examine XARELTO® (rivaroxaban) in these patients. In this 5,780-patient retrospective study, results found patients treated with XARELTO® had a similar risk of recurrent VTE and major bleeding compared to those taking warfarin.
However, treatment with XARELTO® was associated with less all-cause health care resource utilization (HCRU) (e.g., inpatient hospitalizations and outpatient visits) and reduced total medical costs compared to warfarin. Of note, patients taking XARELTO® had an average $2,829 lower total medical costs per patient per year (PPPY) than those taking warfarin, which was mainly driven by lower hospitalization costs.
MedicalResearch.com: What should readers take away from your report?
Response:v XARELTO® is already approved by the U.S. Food & Drug Administration (FDA) for the treatment of VTE, which includes deep vein thrombosis (DVT) and pulmonary embolism (PE).
This study reaffirms what we’ve seen in post-marketing studies and registries, which continue to confirm the safety and efficacy of XARELTO® in routine clinical use across a broad spectrum of patients, including those who are morbidly obese.
MedicalResearch.com: What recommendations do you have for future research as a result of this work?
Response: Real-world research is an important complement to clinical trials, as it helps to build a bridge between what we observed in clinical trials and what we are seeing in routine clinical practice. We remain committed to evaluating and providing real-world data on XARELTO® to ensure physicians and patients are equipped with the latest information.
MedicalResearch.com: Is there anything else you would like to add?
Response: In addition to examining morbidly obese patients with VTE, we recently evaluated the use of XARELTO® to reduce the risk of stroke in morbidly obese patients with non-valvular atrial fibrillation (NVAF). Similar to VTE, treatment of NVAF is complicated among morbidly obese patients and treatment with Factor Xa inhibitors is not recommended in current guidelines due to limited clinical data. We recently presented data at the AHA Scientific Sessions 2018, which found morbidly obese patients treated with XARELTO® or warfarin had similar risk of ischemic stroke and major bleeding; however, treatment with XARELTO® was associated with significantly lower total health care costs PPPY and HCRU than treatment with warfarin in this patient population.
Citation: ASH 2018
Sunday, December 2, 2018, 6:00 PM-8:00 PM
Alex C. Spyropoulos, MD1*, Veronica Ashton, MPH2*, Yen-Wen Chen2*, Bingcao Wu2* and Eric D. Peterson3*
1Department of Medicine, Anticoagulation and Clinical Thrombosis Services, Department of Medicine, Anticoagulation and Clinical Thrombosis Services, Northwell Health System, The Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Manhasset, NY
2Janssen Scientific Affairs, LLC, Titusville, NJ
3Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC
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